Hepatitis, Viral, HumanNCT00608192
HIV and Hepatitis Care Coordination in Methadone Treatment
A study testing Testing, Education, & Counseling (TEC) and Hepatitis Care Coordination (HCC) in people with Hepatitis, Viral, Human and HIV Infections, run by University of California, San Francisco at 2 sites in United States.
Trial summary
This randomized clinical trial will examine the effectiveness of a strategy of HIV and Hepatitis Care Coordination (HCC) consisting of testing, education, counseling and vaccination for methadone maintenance patients compared with standard Testing, Education, and Counseling (TEC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis, Viral, Human, HIV Infections
- What is being tested?
- Testing, Education, & Counseling (TEC) and Hepatitis Care Coordination (HCC)
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 489 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2008to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >=18 years of age
- be able to provide informed consent
- agree to participate in hepatitis/HIV intervention
- expect to be available to participate in the study for the entire duration of the study
- HCV negative, of unknown HCV status, or have not received any previous medical care for HCV
Who cannot join
- have already had a formal hepatitis C evaluation
- are obtaining medical care for hepatitis C
- not interested in obtaining medical care for hepatitis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beth Israel Medical Center Methadone Maintenance Program
New York, New York, 10003
San Francisco General Hospital Opiate Treatment Outpatient Program
San Francisco, California, 94110
About this study
This randomized clinical trial will examine the effectiveness of a strategy of HIV and Hepatitis Care Coordination (HCC) consisting of testing, education, counseling and vaccination for methadone maintenance patients compared with standard Testing, Education, and Counseling (TEC).
Read the detailed description
In the HCC model, HIV and hepatitis screening, and HAV and HBV vaccination will be done on site and participants receive on site theory-based HIV and hepatitis education, counseling, and case management to promote adherence to HIV and HCV evaluation; in TEC hepatitis screening is done on site, but vaccination and medical care will be provided by off site referral. Primary aims are to assess the impact of the HCC intervention on adherence to hepatitis A virus (HAV) and hepatitis B virus (HBV) vaccination and attendance at an initial appointment with an HIV and/or HCV care provider. Secondary aims include examining intervention effects on HIV and hepatitis knowledge, risky behaviors, alcohol use; follow-up with later stages of HIV and hepatitis C care; to identify psychological mediators of intervention outcomes; and to estimate the incremental cost of the HCC intervention to facilitate fuller economic evaluations of the intervention if proven effective.
- Conditions
- Hepatitis, Viral, Human, HIV Infections
- Being tested
- Testing, Education, & Counseling (TEC), Hepatitis Care Coordination (HCC)
- Keywords
- HIV, viral hepatitis, methadone maintenance, case management, costs, vaccination, risk reduction education
- Medical subject headings
- Hepatitis, Viral, Human, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing, Education, & Counseling (TEC)Behavioural
Trained research staff will provide a two-session HIV/hepatitis education class. Participants will also be offered serological testing for hepatitis A, B and C, and HIV (optional), and off-site referrals for vaccination and hepatitis care. The content of the TEC intervention is evidence based. The TEC condition is comparable to screening and education methods commonly used in many drug treatment settings. Those in the TEC intervention group who do not adhere to needed off site vaccinations will be offered on site vaccination 30 days after vaccination referral.
Hepatitis Care Coordination (HCC)Behavioural
HCC Participants will be offered serological testing and counseling for hepatitis A, B and C, and HIV (optional). HCC participants will be offered on-site hepatitis A and B combination vaccination at the methadone clinic. They will also receive a two-session HIV/hepatitis education class with Motivational Interviewing. In addition, participants will receive 6 months of weekly case management to facilitate entry into hepatitis care.
| Study group | Role | What they receive |
|---|---|---|
| Testing, Education, & Counseling (TEC) | Active comparator | HIV and hepatitis screening is done on-site, but vaccination and medical care will be provided by off-site referral. HIV and Hepatitis, Testing, Education, \& Counseling (TEC) participants will receive standard HIV and hepatitis education \& counseling. TEC participants will not receive case management services. Receives: Behavioral: Testing, Education, & Counseling (TEC) |
| Hepatitis Care Coordination (HCC) | Experimental | Participants will receive on-site HIV and viral hepatitis screening. Hepatitis A and B combination vaccination will be provided on-site. Participants will receive on-site theory-based HIV and hepatitis education, counseling, and 6 months of case management to promote adherence to HIV and HCV evaluation. Receives: Behavioral: Hepatitis Care Coordination (HCC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccination adherence visits
Measured: 30 days
Health Care Utilization Survey
Measured: 12 months
Intervention Costs & Hepatitis Care Utilization: DATCAP, public and private health care system administrative databases
Measured: 12 months
Secondary outcomes (6)
Hepatitis A Knowledge Test
Measured: post-intervention & 90 days
Hepatitis B Knowledge Test
Measured: post-intervention & 90 days
Hepatitis C Knowledge Test
Measured: post-intervention & 90 days
HIV Knowledge Test
Measured: post-intervention & 90 days
Risk Behavior Survey
Measured: 3 months, 9 months, 12 months
Addiction Severity Index
Measured: 3 months, 9 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis, Viral, HumanStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 489 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Carmen L Masson, Ph.D., Principal investigator, Univerisity of California, San Francisco, Dept. of PsychiatryDavid Perlman, MD, Principal investigator, Chemical Dependency Institute at Beth Israel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00608192
- Sponsor's protocol ID
- R01DA020781
- Other IDs
- R01DA020781
- Status last verified
- Jan 2013
- First submitted
- 18 Jan 2008
- Last updated
- 16 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV and Hepatitis Care Coordination in Methadone Treatment
- ClinicalTrials.gov ID
- NCT00608192
- Acronym / sponsor ID
- R01DA020781
- Conditions
- Hepatitis, Viral, Human, HIV Infections
- Keywords
- HIV, viral hepatitis, methadone maintenance, case management, costs, vaccination, risk reduction education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 489 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 6 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized clinical trial will examine the effectiveness of a strategy of HIV and Hepatitis Care Coordination (HCC) consisting of testing, education, counseling and vaccination for methadone maintenance patients compared with standard Testing, Education, and Counseling (TEC).
Detailed description
In the HCC model, HIV and hepatitis screening, and HAV and HBV vaccination will be done on site and participants receive on site theory-based HIV and hepatitis education, counseling, and case management to promote adherence to HIV and HCV evaluation; in TEC hepatitis screening is done on site, but vaccination and medical care will be provided by off site referral. Primary aims are to assess the impact of the HCC intervention on adherence to hepatitis A virus (HAV) and hepatitis B virus (HBV) vaccination and attendance at an initial appointment with an HIV and/or HCV care provider. Secondary aims include examining intervention effects on HIV and hepatitis knowledge, risky behaviors, alcohol use; follow-up with later stages of HIV and hepatitis C care; to identify psychological mediators of intervention outcomes; and to estimate the incremental cost of the HCC intervention to facilitate fuller economic evaluations of the intervention if proven effective.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testing, Education, & Counseling (TEC) | Active comparator | Behavioral: Testing, Education, & Counseling (TEC)HIV and hepatitis screening is done on-site, but vaccination and medical care will be provided by off-site referral. HIV and Hepatitis, Testing, Education, \& Counseling (TEC) participants will receive standard HIV and hepatitis education \& counseling. TEC participants will not receive case management services. |
| Hepatitis Care Coordination (HCC) | Experimental | Behavioral: Hepatitis Care Coordination (HCC)Participants will receive on-site HIV and viral hepatitis screening. Hepatitis A and B combination vaccination will be provided on-site. Participants will receive on-site theory-based HIV and hepatitis education, counseling, and 6 months of case management to promote adherence to HIV and HCV evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >=18 years of age
- be able to provide informed consent
- agree to participate in hepatitis/HIV intervention
- expect to be available to participate in the study for the entire duration of the study
- HCV negative, of unknown HCV status, or have not received any previous medical care for HCV
Key exclusion criteria (3 listed)
- have already had a formal hepatitis C evaluation
- are obtaining medical care for hepatitis C
- not interested in obtaining medical care for hepatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testing, Education, & Counseling (TEC)Trained research staff will provide a two-session HIV/hepatitis education class. Participants will also be offered serological testing for hepatitis A, B and C, and HIV (optional), and off-site referrals for vaccination and hepatitis care. The content of the TEC intervention is evidence based. The TEC condition is comparable to screening and education methods commonly used in many drug treatment settings. Those in the TEC intervention group who do not adhere to needed off site vaccinations will be offered on site vaccination 30 days after vaccination referral. | Behavioural | Testing, Education, & Counseling (TEC) |
| Hepatitis Care Coordination (HCC)HCC Participants will be offered serological testing and counseling for hepatitis A, B and C, and HIV (optional). HCC participants will be offered on-site hepatitis A and B combination vaccination at the methadone clinic. They will also receive a two-session HIV/hepatitis education class with Motivational Interviewing. In addition, participants will receive 6 months of weekly case management to facilitate entry into hepatitis care. | Behavioural | Hepatitis Care Coordination (HCC) |
Primary outcome
Vaccination adherence visits
Time frame: 30 days
Health Care Utilization Survey
Time frame: 12 months
Intervention Costs & Hepatitis Care Utilization: DATCAP, public and private health care system administrative databases
Time frame: 12 months
6 secondary outcomes
Hepatitis A Knowledge Test
Time frame: post-intervention & 90 days
Hepatitis B Knowledge Test
Time frame: post-intervention & 90 days
Hepatitis C Knowledge Test
Time frame: post-intervention & 90 days
HIV Knowledge Test
Time frame: post-intervention & 90 days
Risk Behavior Survey
Time frame: 3 months, 9 months, 12 months
Addiction Severity Index
Time frame: 3 months, 9 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen L Masson, Ph.D. principal investigator
Univerisity of California, San Francisco, Dept. of Psychiatry
David Perlman, MD principal investigator
Chemical Dependency Institute at Beth Israel Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Testing, Education, & Counseling (TEC) and Hepatitis Care Coordination (HCC) in people with Hepatitis, Viral, Human and HIV Infections, run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccination adherence visits (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2013.